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Requirement
The ethical and legal issues related to the research on the treatment of Zika virus
Solution
Executive summary
Zika virus is that harmful virus which enters into the body of pregnant women and hit the fetus due to which it develops microcephaly. The report aims to decide what type of stem cells to use by conducting some preliminary research on the types of stem cells. The legal and ethical issues related to the use of stem cells, the unborn babies, the pregnant women and the potential for further international spread of the Zika virus has been discussed. Based on this report, company ABC will carry out some further research to acquire the stem cells. Before they can do that research they will need to get approval from the Ethics Committee. So, they need to be aware of the ethical issues when they are designing their research. So, this report has outlined the steps that they should undertake to ensure that their research is ethical. Along with this, the report has addressed essential ethical components in the research. It has been concluded that the scientists, doctors and researchers should use the Induced Pluripotent Stem Cells and ABC should go for experimental/laboratory research.
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Introduction
Zika virus is caused by Aedes mosquito, the same mosquito that causes dengue and chikungunya. When the unborn babies are hit by this virus during the phase of pregnancy, they are born with serious birth defects and other problems also arise with the pregnancy (Evidence shows Zika virus crosses placental barrier, 2016). The adults are found to be hit by the Guillain-Barré syndrome (GBS) in which the nervous system of the people gets damaged and they suffer from muscular weakness and get paralyzed. When the pregnant ladies are hit by this virus, the fetus develops microcephaly which is a defect in the head due to which the head of the baby becomes abnormally small and the brain does not develops in an appropriate manner (Torjesen, 2016).
Company ABC has produced a gene therapy technique that will reduce the development of microcephaly in the unborn babies of pregnant woman who have become infected with the Zika virus. The therapy requires the use of stem cells and company ABC will need a large supply of them to treat the wider community. Clinical trials have shown that when adult stem cells are used there is a 15% reduction in microcephaly. When embryo stem cells under 14 days old are used there is a reduction in microcephaly of 50%. When embryo stem cells over 14 days old are used there is a reduction in microcephaly of 100%.
Company ABC needs a large supply of stem cells for their gene therapy technique but they are unsure of what type of stem cells to use. All they know at this stage is that they want to acquire the stem cells legally and ethically. Company ABC is a huge multinational company and can set up their laboratory anywhere in the world.
Therefore, the purpose of this report is to decide what type of stem cells to use by conducting some preliminary research on the types of stem cells. The legal and ethical issues related to the use of stem cells, the unborn babies, the pregnant women and the potential for further international spread of the Zika virus will also be discussed. Based on this report, Company ABC will be carrying out some further research to acquire the stem cells. Before they can do that research they will need to get approval from the Ethics Committee. So, they need to be aware of the ethical issues when they are designing their research. So, this report will also outline the steps that they should undertake to ensure that their research is ethical. Along with this, the report will address essential ethical components in the research.
Types of stem cells
The characteristic of the stem cell is that they renew themselves which means that they are able to maintain their undifferentiated state during the process of cell division. Also, they are characterized by potency which means that they have the ability to differentiate themselves in the cells of special types.
Basically, there are three kinds of the stem cells. They are:
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1. Embryonic Stem Cells: These are those cells that are separated from the interior mass of the cell of the blastocysts during the pre-implantation stage of the embryo. Particular signals are needed for differentiating the cell type that is desired. If it is to be directly injected, then the cell will get differentiated into various cells and thus, a tumor will be generated from the abnormal pluripotent development of the cell. These cells pose specific challenges related to the directed differentiation of these cells and the rejection if the transplantation. These cells have the potential to expand in an unlimited amount and these are also the source of the regenerative medicine and the replacement of the tissue after any kind of disease or injury (Krämer et al., 2012).
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2. The adult stem cells: When these cells are produced, there is no harm to the embryo and it is not destructed. These are obtained from the auto graft i.e. the intended recipient and there is no risk of the rejection of the immune. Some disease like leukemia has been treated with these methods and other bone related or the blood related diseases. This is also used for the transplantation of the bone marrow (Baker, 2009).
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3. Induced Pluripotent Stem Cells: These cells are the somatic cells which are reprogrammed genetically to the state of an embryonic stem. These stem cells maintain the defining properties of the embryonic cells. These are useful when the drug needs to be developed and the diseases are needed to be modeled. The main use of these cells is seen in the transplantation of the medicines. The tissues that are obtained from these cells are identical to the donor of the cells and therefore the possibility of the rejection by the immune system is very less. These cells give the knowledge about the reprogramming of the cells and the repair of the tissues that get damaged inside the body of the human’s injury (Krämer et al., 2012).
The legal and ethical issues related to the use of stem cells, the unborn babies, the pregnant women and the potential for further international spread of the Zika virus
The stem cells generate hope for the success of the therapies but their use is debated in the world. The use of these cells in the countries across the world is very different because there are various ethical and legal issues related to their use. Some of them are as follows:
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• There is a moral dilemma in the use of the embryonic stem cell. The researchers and scientists feel that they should prevent the suffering or alleviate the suffering. Also, it is the duty of the people that they respect the value of the life of the humans. But, when the use of stem cells is made, these moral principles are not respected. For example, if the Embryonic stem cell is to be used, there is need to destroy the early embryo which is nothing but the destruction of the potential human life (Dhai, 2015). So, in this case a major ethical issue is aroused.
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• When the embryo gets fertilized, it obtains a moral status and it seen as a person. So, it is unethical to destroy a person while using the stem cells.
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• As far as legal requirements are concerned, the consent is to be obtained for the donation of the materials if the use of stem cells is to be made (Gracia and Woodruff, 2016). It is required by the law that the informed consent is required to be obtained for the potential future users of the donated embryo.
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• Sometimes, the donors of the gamete helps in the creation of frozen embryos but these donors do not participate in the further process of reproduction (Ishii, Pera and Greely, 2013). But when the stem cells of that embryo is to be used, the consent of the donors is to be taken because the embryo id developed form their sperms and oocyte.
Recommendations on the type of stem cells to be used
The scientists, doctors and researchers should use the Induced Pluripotent Stem Cells. This is because these cells are used for creating the cells or the tissues that are required by the body of the humans for countering and fighting with the many diseases like the diabetes, the injury in the cord, the leukemia , heart disease etc. Also, these cells are customized and they give a genetic match which is almost perfect for the patients. Thus, the patients can be treated with ease, the transplants can be done without matching the cells and the tissues and the problems of the tissue rejection can be avoided (CHEN and SHI, 2012). Also, the patients do not have to take the powerful immune-suppressing drugs after their treatment throughout their lives. Not only in the treatments, but this cell are very useful in the study of the unfolding of the diseases that can be done in the labs. So, the scientists and pinpoint and keep track of the diseases at the early stages by observing the development of harmful cells. Finally, it is recommended that these types of cells should be used because they make many new discoveries about the human body including the premature aging, the risk of the heart disease and cancer etc. (High-yield induced pluripotent stem (iPS) cells, 2010). They have the characteristic of getting manipulated because they are made from the cells of humans so, they have the ability to fix the diseases and thus the healthy cells can be made for the transplantation.
Ethical issues related to the design of the research carried out by Company ABC
The design of the research that the company ABC should adopt is the experimental/laboratory research design. This is because in their research design, the researcher will have maintained the control over the factors that affect the result of an experiment. This design is important for this company because it will help the company in predicting the outcome. Here, the priority is given to the time and the causal relation is determined. The causal relationship should be consistent because then only the researcher will be able to predict the effect of something on the other. The study that the company ABC is searching is the one that is very technical and important for the welfare of the people. So, the level of evidence required for this should be highest.
The ethical issues related to this are:
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• The scientists who conduct this study have to take care of the community and society at large. Their experiments must contribute to the welfare of the people. The study on stem cells is very crucial study and is related to the health of the people (McGee, 2005). So, it must be conducted with an objective to help the society and not for any personal use.
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• The planning, conduct and the design of the report should be in accordance with the standards of the scientific competence that is recognized and is ethical too. The standards specify all the acceptable practices so if they are followed, that means that ethics are followed.
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• The possibility of the errors in this kind of research should be minimized. The scientists cannot afford to waste the things that will be used here for the experiments like the stem cells etc.
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• The research should be conducted with the approval of the host institution that will be made a part of the study (Wells, 2009). Also, the researcher has to provide the exact and accurate information about the institution. If they are hiding some important information, then that would be considered as unethical.
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• The researcher has some responsibilities while conducting the research. Like, he has to conduct the survey in an authentic manner; he has to obtain the consent of the respondents’ before making them a part of the research.
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• There are some federal and state law and regulations that have to be followed by the researchers. If they do not follow them, then it is regarded as unethical.
Steps that they should undertake to ensure that their research is ethical
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• The things for the experiments should be obtained in an ethical manner. The variables should be picked in a proper way and ethical way by doing proper research. Also, the variables should relate to the research rather than picking the variables randomly.
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• When the embryo gets fertilized, it obtains a moral status and it seen as a person. So, it is unethical to destroy a person while using the stem cells. Therefore, the researcher should mention all the considerations while conducting the research. The researcher should mention the relevant literature review in the research.
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• For the research, the collection of the data is an important step and thus the collection of the data should be proper and ethical. The data should be reliable and valid. It should be authentic. The data forms the basis for all the future research. The respondents should be told in advance that for what are the responses taken and how will the responses add to the completion of the results.
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• The results of the experiments must be authentic and they must be clearly displayed in the research. The cause and the effect relations are the major analysis in this research. So, the analysis and the causal relation must be made using proper software like the SPSS and the proof of the results must be clearly displayed in the records.
Conclusion and recommendations
From the above discussion, it can be concluded that Zika virus is caused by Aedes mosquito, the same mosquito that causes dengue and chikungunya. When the unborn babies are hit by this virus during the phase of pregnancy, they are born with serious birth defects and other problems also arise with the pregnancy. The adults are found to be hit by the Guillain-Barré syndrome (GBS) in which the nervous system of the people gets damaged and they suffer from muscular weakness and get paralyzed. When the pregnant ladies are hit by this virus, the fetus develops microcephaly which is a defect in the head due to which the head of the baby becomes abnormally small and the brain does not develops in an appropriate manner. The characteristic of the stem cell is that they renew themselves which means that they are able to maintain their undifferentiated state during the process of cell division. Also, they are characterized by potency which means that they have the ability to differentiate themselves in the cells of special types. The scientists, doctors and researchers should use the Induced Pluripotent Stem Cells. The stem cells generate hope for the success of the therapies but their use is debated in the world. The use of these cells in the countries across the world is very different because there are various ethical and legal issues related to their use. Appropriate steps have to be undertaken to ensure that their research is ethical. For example, the things for the experiments should be obtained in an ethical manner. The variables should be picked in a proper way and ethical way by doing proper research. Also, the variables should relate to the research rather than picking the variables randomly.
It is recommended that, for the research, the collection of the data is an important step and thus the collection of the data should be proper and ethical. The data should be reliable and valid. It should be authentic. The data forms the basis for all the future research. The respondents should be told in advance that for what are the responses taken and how will the responses add to the completion of the results. The results of the experiments must be authentic and they must be clearly displayed in the research. The cause and the effect relations are the major analysis in this research. So, the analysis and the causal relation must be made using proper software like the SPSS and the proof of the results must be clearly displayed in the records.
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Anon, 2016. Evidence shows Zika virus crosses placental barrier. Clinical Pharmacist.
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Anon, 2010. High-yield induced pluripotent stem (iPS) cells. Science-Business eXchange, 3(8).
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Baker, M., 2009. iPS cells used to probe rare neurodegenerative disease. Nature Reports Stem Cells.
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CHEN, Q. and SHI, Q., 2012. The genetic safety of induced pluripotent stem (iPS) cells. Hereditas (Beijing), 34(3), pp.260-268.
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Dhai, A., 2015. The use of stem cells in research and therapies: Ethical, legal and social issues. S Afr J BL, 8(2), p.2.
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Gracia, C. and Woodruff, T., 2016. Use of Very Small Embryonic-Like Stem Cells to Avoid Legal, Ethical, and Safety Issues Associated With Oncofertility—Reply. JAMA Oncology, 2(5), p.689.
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Ishii, T., Pera, R. and Greely, H., 2013. Ethical and Legal Issues Arising in Research on Inducing Human Germ Cells from Pluripotent Stem Cells. Cell Stem Cell, 13(2), pp.145-148.
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Krämer, N., Issa, L., Neubert, G., Seiler, A., Ninnemann, O. and Kaindl, A., 2012. Microcephaly and Effects of Cdk5rap2 Downregulation in Murine Embryonic Stem Cells. Neuropediatrics, 43(02).
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McGee, P., 2005. Ethical Issues in Research Design. Research Ethics, 1(4), pp.134-134.
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Torjesen, I., 2016. Zika virus outbreaks prompt warnings to pregnant women. BMJ, p.i500.
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Wells, F., 2009. Ethical Issues in the Design of Patient Information Sheets for Research Purposes. Pharmaceutical Medicine, 23(1), pp.3-5.
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